oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder

Not Applicable

Completed

• Conditions: Social Anxiety
• Interventions: Other: oVRcome phone app with headset

• Registration Number: NCT05576259
• Lead Sponsor: University of Otago

Brief Summary

Social anxiety is characterised by excessive fear of being negatively judged, embarrassed or humiliated during social interactions and is common with a lifetime prevalence of 12.1%. Cognitive behavioural therapy is the first line of treatment, but people may not seek treatment due to a number of factors including the discomfort experienced in seeking help, inconvenience, and the experience of psychotherapy itself. With Virtual Reality (VR), users can have increased control in how gradually they expose themselves to social situations. In studies of VR in people with specific phobias, 76% of people prefer VR exposure to in vivo exposure. There is emerging evidence for the use of VR in social phobia.

oVRcome, is a self-help VRET for social anxiety symptoms and specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video.

This study will evaluate the effectiveness of the oVRcome social anxiety program for social anxiety symptoms. We hypothesize that oVRcome will reduce social anxiety symptom severity over a 6-week treatment period compared to waiting-list control

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-08
• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-09
• Study First Posted: 2022-10-12
• Primary Completion: 2023-07-01
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• are between 18-64 years old
• have moderate (or higher) social anxiety disorder symptoms on Liebowitz social anxiety scale (>60)
• have access to a smart phone and internet
• willing to participate in the research study and providing informed consent

Exclusion Criteria

• present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19, =3 on suicidality item
• have insufficient knowledge of the English language
• are under current treatment for social phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone application (app) in combination with headset	oVRcome phone app with headset	The intervention oVRcome is self-help VRET for social anxiety, that is delivered through a smartphone application (app) in combination with headset that holds the smartphone and uses 360º video. oVRcome includes 6 modules of psychoeducation, relaxation, mindfulness, cognitive techniques, exposure through VR, and a relapse prevention module which are aimed to be completed weekly.

Primary Outcome Measures

Name	Time	Method
Liebowitz social anxiety scale -self report (LSAS)	Week 6	Assesses the way that social phobia plays a role in participants life across a variety of situations. Higher scores indicate more severe symptoms. Min 0 Max 144

Secondary Outcome Measures

Name	Time	Method
Brief Fear of Negative Evaluation Scale	week 0,6,12,18	Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation
Modified Gatineau Presence Questionnaire First item	Week 4,5,6	Assess degree of realism using virtual reality. Scores range from 1 (very realistic) through to 100 (not very realistic)
Patient Health Questionnaire - PHQ 9	Week 0,6,12,18	PHQ-9 scores range from 0 through to 27, with higher scores indicating more severe depressive symptoms
Changes in behaviour that may have been previously avoided because of the phobia	Week 6,12,18	Free text response
Patient's Global Impressions of Improvement (PGI-I) scale	Week 1,2,3,4,5,6,7,8,9,10,11,12,18	Assesses patients' overall perception of their condition in a 1-item questionnaires that ask an individual patient to rate the perceived change in his/her condition in response to therapy at endpoint. Min 1 (very much improved) Max 7 (very much worse).
Fast Motion Sickness Scale (FMS)	Week 4,5,6	Measures motion sickness with virtual reality. Scores range from zero (no sickness at all) to 20 (frank sickness).

Trial Locations

Locations (1)

University of Otago; 🇳🇿 Christchurch, New Zealand